Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Solution for injection, one subcutaneous injection.
• Placebo (for Dupilumab) — DRUG
  Solution for injection, one subcutaneous injection.
• Fluticasone/Salmeterol combination therapy — DRUG
  Oral inhalation twice daily.
• Fluticasone monotherapy — DRUG
  Oral inhalation twice daily.
• Albuterol — DRUG
  Oral inhalation as needed.
• Levalbuterol — DRUG
  Oral inhalation as needed.

Study Details

Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: * To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. * To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.

Key Dates

Start date

Mar 31, 2011

Status verified

Jun 2017

Primary completion

Oct 31, 2012

Completion

Oct 31, 2012

Study Design

Enrollment

104 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo (for Dupilumab)
  Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of inhaled corticosteroids/long-acting beta2-adrenergic agonist (ICS/LABA) (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
• Experimental: Dupilumab 300 mg qw
  Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.

Primary Outcome Measure

Percentage of Participants With Asthma Exacerbation [ Time Frame: Baseline up to Week 12 ]

Locations (50)

Find similar trials in Anaheim, CA

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